Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b
Rhea-AI Summary
Lipella Pharmaceuticals (NASDAQ: LIPO) announced FDA guidance for its lead product, LP-10, in a Type-C meeting. LP-10, intended for moderate to severe hemorrhagic cystitis, will enter Phase 2b trials in the second half of 2024. The trial will include around 36 patients and will focus on objectives, safety, control group monitoring, dosing, efficacy endpoints, and sample size. Previous Phase 2a studies showed positive results with improved urinary symptoms in 13 patients. This FDA feedback allows Lipella to proceed confidently with their next trial phase, enhancing their value proposition.
Positive
- FDA guidance received for Phase 2b clinical trial.
- Phase 2b trial set for 2H 2024 with approximately 36 patients.
- Previous Phase 2a study showed positive results on urinary symptoms.
- FDA preliminary agreement on trial design, objectives, safety monitoring, and sample size.
Negative
- Only 13 patients were treated in the Phase 2a study, which may be considered a small sample size.
- Potential delay risks as Phase 2b trial is scheduled for the second half of 2024.
News Market Reaction
On the day this news was published, LIPO declined 3.55%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Company to initiate Phase 2b clinical trial in lead asset, LP-10 in 2H 2024
PITTSBURGH, May 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, announced today the receipt of U.S. Food & Drug Administration (“FDA”) Type-C meeting guidance regarding the LP-10 (liposomal tacrolimus) clinical program. Lipella expects to initiate a Phase 2b clinical trial evaluating LP-10 as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024.
The FDA provided preliminary agreement on Lipella’s overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations.
Lipella’s Chief Medical Officer, Dr. Michael Chancellor, stated, “We can now proceed with the confidence that our Phase 2b study design can successfully meet its regulatory objectives. This clarity significantly advances our value proposition.”
LP-10 is an intravesical liposomal formulation of tacrolimus, intended for the treatment of moderate to severe hemorrhagic cystitis. Lipella has demonstrated preliminary safety and efficacy of LP-10 in a Phase 2a study, which treated 13 patients with up to two courses of LP-10 intravesical bladder instillations, and resulted in improved urinary symptoms, including decreased hematuria, decreased cystoscopic bleeding, and a reduced number of ulceration sites. Pharmacokinetic analysis demonstrated LP-10’s very short duration of systemic uptake.
About Hemorrhagic Cystitis
Hemorrhagic cystitis is a chronic condition involving significant urinary blood loss associated with certain cancer therapies. There are currently no FDA approved treatments for moderate to severe hemorrhagic cystitis, a highly morbid and sometimes fatal condition. Lipella is targeting a patient population of approximately 60,000 annually.
About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, the company maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella recently completed an initial public offering in December 2022. For more information, visit www.lipella.com or LinkedIn for updates.
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Contact
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
ir@lipella.com
1-412-894-1853
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
FAQ
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